1. Field
This application relates to adjustable tourniquet for venous flow control, specifically for treating erectile dysfunction.
2. Prior Art
Numerous treatments for impotence are known in the art, and include psychological therapies, hormonal therapy, administration of various vasodilators, surgery (e.g. vascular surgery or implantation of penile prosthesis). Vacuum devices and various external aids such as penile splints and constriction devices. More particularly U.S. Pat. No. 5,810,710 to Burgos describes constriction device composed of a pair of rigid C-shaped members hinged joined to form said split-ring. The disadvantage of this device is that it has to be applied prior to erection and is very difficult if not impossible to adjust once in place especially after erection has taken place. It is also rigid and could be uncomfortable and bothersome to one or both partners. U.S. Pat. No. 3,461,863 to Sullinger describes an adjustable constriction device consisting of a loop of flexible tubing having two apertures arranged at one end of the tubing which allow the other end to pass through and provide a means for fastening the device in place. Sullinger further describes the importance of the relative spacing of the two apertures and tube wall thickness to prevent or resist slippage of the device in response to the increased tension. The disadvantage of this device is that it could present a hygienic problem. U.S. Pat. No. 5,855,548 to Virgil A. describes a venous flow control device assisting in the maintenance of a penile erection or in preventing urinary incontinence. The device is a tubular structure adapted to be secured in a loop configuration about the penis to provide an adjustable radial constrictive force, about the base of the penis. One dis-advantage is it does not have a positive locking mechanism. The VFC device has a tendency to loosen during sexual intercourse especially a vigorous one. Another factor that could loosen the device is the presence of natural vaginal lubricant or personal lubricant applied to the penis and/or the vaginal area which could result in the slipping of the device resulting in loss of rigidity of the penis. The grasping means at both distal and proximal ends are formed by inserting annular or plastic rings. The insertion of annular bodies into the tubing does not provide a leak proof seal. Washing the unit with soap and water after each use can cause leakage into the tubing, which can be a source of contamination. Since the tubing material used in prior art is an opaque off-white colored latex and ‘O’ rings are used to seal the ends of the tubing, it is difficult to see the soapy solution seeping into the tubing. Therefore, any fluid, natural or otherwise can enter the tubing becoming an environment for bacteria to proliferate.
Although these devices, as well as other types of constriction or clamping devices known in the art, are capable of restricting blood flow from the penis, these devices are subject to several disadvantages in the treatment or prevention of erectile failure. One common disadvantage involves a lack of means to adjust tension and lock the device in place. It is important to restrict veinal outflow to maintain penile rigidity. Insufficient restriction prevent such devices to maintain an erection. Too much restriction may result in user discomfort, numbness and insensitivity which may result in damage to the penile tissue especially if left in place for an extended period of time. Some devices can not be adjusted without removing the clamping device resulting in loss of penile rigidity. Furthermore, since the degree of veinal restriction provided by prior devices depends in part on the stage of the individual's erection, a problem arises when such devices are adjusted to achieve tightness suitable for initial erection but subsequently becomes too restrictive thereafter.